Broome Oncology

FDA Approves Ruxience Biosimlar to Rituxan

The FDA approved rituximab-pvvr, a rituximab biosimilar, for use
alone or in combination with chemotherapy for the treatment of adults with
CD20-positive, B-cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic
leukemia (CLL), as well as granulomatosis with polyangiitis and microscopic
polyangiitis. This is the second biosimilar to rituximab that has been approved
by the FDA.

This
approval was based on a review of comprehensive data demonstrating the
biosimilarity of rituximab-pvvr to the reference drug, rituximab.

“Rituximab
became one of the first monoclonal antibody (mAb) cancer treatments when it was
initially approved by the FDA, representing a significant treatment advance and
the only option available to oncologists and their patients for a period of
time,” said Jeff Sharman, MD, Medical Director, US Oncology Hematology
Research, in a press release.

“With
this FDA approval, clinicians have an additional treatment option that will
help improve access to care for patients in need of anti-CD20 mAb therapy,” he
added.

The
most common adverse effects of rituximab-pvvr are infusion-related reactions,
fever, low white blood cells count, chills, infection, weakness, nausea,
diarrhea, headache, muscle spasms, low red blood cell count, and swelling.

Source: FDA
approves Pfizer’s biosimilar, RUXIENCE (rituximab-pvvr), for certain cancers
and autoimmune conditions [news release]. New York, NY: Business Wire; July 23,
2019. https://www.businesswire.com/news/home/20190723005823/en/FDA-Approves-Pfizer%E2%80%99s-Biosimilar-RUXIENCE%E2%84%A2-rituximab-pvvr-Cancers.
Accessed July 23, 2019.

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